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Nancy audits full time, focusing on computer systems and data
integrity for pharmaceutical and medical device manufacturers. Audits include
ISO 13485:2016 certification audits, supplier assessments, and internal audits
across a wide range of manufacturers, laboratories, and service providers. She
has over 30 years’ experience in software systems development, maintenance, and
management on pharmaceutical, medical device, clinical, military, and
commercial projects. She spent years providing computer system validation
services and training to medical device and pharmaceutical companies.
Nancy holds a BS in Computer Science, holds ASQ CSQE and CBA
certifications, and is past Treasurer and Secretary of the ASQ Software
Division, past treasurer of the ASQ San Diego section (703), and served on the
board of the San Diego Society for Software Quality. Nancy travels whenever the
opportunity arises and can otherwise be found wandering around in the San Diego
sunshine.
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